Inserter/impactor for implanting an artificial intervertebral disc

ABSTRACT

An instrument is provided for holding, inserting, repositioning, removing, impacting, extracting, and otherwise manipulating an artificial intervertebral disc having features suitable for being manipulated thereby. A spring-loaded holding pin on the instrument can be used to engage a corresponding hole on the disc and confront the angled surfaces of the disc to enable the holding and manipulation of the disc. A forward wedge extension on the instrument has upper and lower surfaces that engage inwardly facing surfaces of the disc to hold the baseplates of the disc at a preferred lordosis angle with respect to one another. The instrument can engage the disc from a variety of surgical approach angles.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuing application of U.S. patentapplication Ser. No. 10/425,267, filed Apr. 29, 2003, which is acontinuing application of U.S. patent application Ser. No. 10/282,356,filed Oct. 29, 2002, entitled “Instrumentation and Methods For Use InImplanting an Artificial Intervertebral Disc,” which is a continuingapplication of U.S. patent application Ser. No. 10/256,160, filed Sep.26, 2002, entitled “Artificial Intervertebral Disc Having LimitedRotation Using a Captured Ball and Socket Joint With a Solid Ball andCompression Locking Post,” which is a continuing application of U.S.patent application Ser. No. 10/175,417, filed Jun. 19, 2002, entitled“Artificial Intervertebral Disc Utilizing a Ball Joint Coupling,” whichis a continuing application of U.S. patent application Ser. No.10/151,280, filed May 20, 2002, entitled “Tension Bearing ArtificialDisc Providing a Centroid of Motion Centrally Located Within anIntervertebral Space,” which is a continuing application of both U.S.patent application Ser. No. 09/970,479, filed Oct. 4, 2001, entitled“Intervertebral Spacer Device Utilizing a Spirally Slotted BellevilleWasher Having Radially Extending Grooves,” as well as U.S. patentapplication Ser. No. 10/140,153, filed May 7, 2002, entitled “ArtificialIntervertebral Disc Having a Flexible Wire Mesh Vertebral Body ContactElement,” the former being a continuing application of U.S. patentapplication Ser. No. 09/968,046, filed Oct. 1, 2001, entitled“Intervertebral Spacer Device Utilizing a Belleville Washer HavingRadially Extending Grooves” and the latter being a continuingapplication of both U.S. patent application Ser. No. 09/970,479, notedabove, as well as U.S. patent application Ser. No. 10/128,619, filedApr. 23, 2002, entitled “Intervertebral Spacer Having a Flexible WireMesh Vertebral Body Contact Element”, which is a continuing applicationof both U.S. patent application Ser. No. 09/906,119, filed Jul. 16, 2001and entitled “Trial Intervertebral Distraction Spacers,” as well as U.S.patent application Ser. No. 09/982,148, filed Oct. 18, 2001 and entitled“Intervertebral Spacer Device Having Arch Shaped Spring Elements.” Allof the above mentioned applications are hereby incorporated by referenceherein in their respective entireties.

FIELD OF THE INVENTION

This invention relates generally to systems and methods for use in spinearthroplasty, and more specifically to instruments for inserting andimpacting artificial intervertebral discs, and methods of use thereof.

BACKGROUND OF THE INVENTION

The bones and connective tissue of an adult human spinal column consistsof more than twenty discrete bones coupled sequentially to one anotherby a tri-joint complex that consists of an anterior disc and the twoposterior facet joints, the anterior discs of adjacent bones beingcushioned by cartilage spacers referred to as intervertebral discs.These more than twenty bones are anatomically categorized as beingmembers of one of four classifications: cervical, thoracic, lumbar, orsacral. The cervical portion of the spine, which comprises the top ofthe spine, up to the base of the skull, includes the first sevenvertebrae. The intermediate twelve bones are the thoracic vertebrae, andconnect to the lower spine comprising the five lumbar vertebrae. Thebase of the spine is the sacral bones (including the coccyx). Thecomponent bones of the cervical spine are generally smaller than thoseof the thoracic spine, which are in turn smaller than those of thelumbar region. The sacral region connects laterally to the pelvis. Whilethe sacral region is an integral part of the spine, for the purposes offusion surgeries and for this disclosure, the word spine shall referonly to the cervical, thoracic, and lumbar regions.

The spinal column is highly complex in that it includes these more thantwenty bones coupled to one another, housing and protecting criticalelements of the nervous system having innumerable peripheral nerves andcirculatory bodies in close proximity. In spite of these complications,the spine is a highly flexible structure, capable of a high degree ofcurvature and twist in nearly every direction.

Genetic or developmental irregularities, trauma, chronic stress, tumors,and degenerative wear are a few of the causes that can result in spinalpathologies for which surgical intervention may be necessary. Withrespect to the failure of the intervertebral disc, and the insertion ofimplants and/or height restorative devices, several methods and deviceshave been disclosed in the prior art that achieve immobilization and/orfusion of adjacent bones by implanting artificial assemblies in or onthe spinal column. More recently, the development of non-fusion implantdevices, which purport to permit continued natural movement in thetri-joint complex, have provided great promise as a preferablyalternative to fusion devices. The region of the back that needs to becorrected, as well as the individual variations in anatomy, determinesthe appropriate surgical protocol and implantation assembly. Generally,the preparation of the intervertebral space for the receipt of fusion ornon-fusion devices involves removing the damaged disc material andthereafter distracting the adjacent vertebral bones to their appropriatedistance apart. Once the proper height of the intervertebral space isrestored, the fusion or non-fusion device can be implanted.

It is an object of the invention to provide instrumentation and methodsthat enable surgeons to more accurately, easily, and efficiently implantfusion or non-fusion devices. Other objects of the invention notexplicitly stated will be set forth and will be more clearly understoodin conjunction with the descriptions of the preferred embodimentsdisclosed hereafter.

SUMMARY OF THE INVENTION

The preceding objects are achieved by the invention, which includes,among other aspects, an inserter/impactor (sometimes referred to hereinas an “inserter/impactor”) useful for holding and manipulatingartificial intervertebral discs.

More particularly, the systems and methods disclosed herein are intendedfor use in spine arthroplasty procedures, and specifically for use withthe systems and methods described herein in conjunction with the systemsand methods in conjunction with the systems and methods described inU.S. patent application Ser. No. 10/282,356 (filed Oct. 29, 2002)entitled “Instrumentation and Methods For Use In Implanting anArtificial Intervertebral Disc” (hereinafter referred to as “the '356application”) as well as U.S. patent application Ser. No. 10/256,160(filed Sep. 26, 2002) entitled “Artificial Intervertebral Disc HavingLimited Rotation Using a Captured Ball and Socket Joint With a SolidBall and Compression Locking Post” (hereinafter referred to as “the '160application”) as well as U.S. patent application Ser. No. 09/906,127(filed Jul. 16, 2001) entitled “Insertion Tool For Use WithIntervertebral Spacers” (hereinafter referred to as “the '127application”), both applications of which are mentioned above. However,it should be understood that the systems and methods described hereinare also suitable for use with other systems and methods withoutdeparting from the scope of the invention.

While the instrumentation described herein (e.g., the inserter/impactor)will be discussed for use with the artificial intervertebral disc ofFIGS. 1 a-h of the present application (hereinafter, such figures willmerely be referred to as “FIGS. 1 a-h”), such discussions are merely byway of example and not intended to be limiting of their uses. Thus, itshould be understood that the instrumentation and methods can be usedwith any of the artificial intervertebral discs disclosed in the '356 or'160 applications, or any other artificial intervertebral disc having(or being modifiable or modified to have) suitable features therefor.Moreover, it is anticipated that the features of the artificialintervertebral discs (e.g., plate surfaces and engagement holes) thatare used by the inserter/impactor discussed herein to hold and/ormanipulate the artificial intervertebral disc can be applied,individually, or collectively or in various combinations, to othertrials, spacers, artificial intervertebral discs, or other orthopedicdevices as stand-alone innovative features for enabling such trials,spacers, artificial intervertebral discs, or other orthopedic devices tobe more efficiently and more effectively held and/or manipulated by theinserter/impactor described herein or by tools having suitable features.In addition, it should be understood that the invention encompassesinstrumentation and methods for implanting artificial intervertebraldiscs, spacers, trials (static or dynamic), and/or other orthopedicdevices, that have one or more of the features disclosed herein, in anycombination, and that the invention is therefore not limited toartificial intervertebral discs, spacers, trials, and/or otherorthopedic devices having all of the features simultaneously.

Preferably, with regards to each artificial intervertebral disc to beimplanted, a plurality of sizes of the artificial intervertebral discwould be available (e.g., the artificial intervertebral disc 160 ofFIGS. 1 a-h). That is, preferably, a plurality of the same type ofartificial intervertebral disc would be available, each of the pluralityhaving a respective width and depth dimension combination that allows itto fit within a correspondingly dimensioned intervertebral space. Forexample, the plurality of artificial intervertebral discs could includeartificial intervertebral discs having widths being either 35 mm or 40mm, and depths ranging from 14 mm to 18 mm in 1 mm increments, for atotal of 10 discs. It should be understood that the artificialintervertebral discs can be offered in a variety of dimensions withoutdeparting from the scope of the invention, and that the dimensionsspecifically identified and quantified herein are merely exemplary. Eachof the plurality of artificial intervertebral disc preferably furtherincludes features that can be used by the inserter/impactor (describedbelow) and/or the inserter/impactor described in the '356 application.

With regard to features that can be used by the inserter/impactordescribed in the '356 application, each artificial intervertebral discincludes an anteriorly facing flat surface, flanked by twoanteriolaterally facing flat surfaces (one on each side of theanteriorly facing flat surface), and, to provide for holding of the discfor an anterior insertion approach, a hole spaced from the anteriorlyfacing flat surface, the hole having a longitudinal axis parallel to theanteriorly facing flat surface. The holding pin of the inserter/impactorfits within the hole, and the angled flat surfaces of the disc fitagainst the correspondingly angled flat surfaces of theinserter/impactor, and operation of the inserter/impactor pulls theholding pin toward the flat surface of the inserter/impactor oppositethe pin, to rigidly hold the disc by the lower baseplate. The holdingpin protrudes from the wedge-shaped extended surface of the distal endof the inserter/impactor and is restricted from upward movement withrespect to the distal head by the presence of the wedge-shaped extendedsurface of the distal end of the inserter/impactor. More particularly,with any attempted upward movement of the holding pin, the pinencounters the upper surface of the channel in which the pin travels,preventing any such upward movement. When the intervertebral disc isheld in this manner, rotation of the disc about a longitudinal axisrelative to the inserter/impactor is prevented by interference of thecorners of the disc's flat surfaces and the corners of theinserter/impactor's flat surfaces, similar to the manner in which awrench holding a nut prevents rotation of the nut relative to thewrench. Further, when the disc is held in this manner, rotation of thedisc about a lateral axis of the disc relative to the inserter/impactoris prevented by interference of the inwardly facing surface of the firstbaseplate (e.g., upper baseplate) of the disc and the correspondingsurface (e.g., upper surface) of the wedge on the distal end, and byinterference of the inwardly facing surface of the second baseplate(e.g., lower baseplate) of the disc and the corresponding surface (e.g.,lower surface) of the wedge on the distal end. It is preferable that thewedge on the inserter/impactor will interfere between the first andsecond baseplates (e.g., upper and lower) so that the surfaces of thefirst and second baseplates align at a preferred 15 degrees angle oflordosis when the disc is held by the inserter/impactor.

Preferably, in order to provide for a holding of the disc for twoadditional (here, anteriolateral) insertion approaches, each disc alsoinclude two additional holes, one spaced apart from one of theanteriolaterally facing flat surfaces, and the other spaced apart fromthe other of the anteriolaterally facing flat surfaces. Accordingly,operation of the inserter/impactor can fit the holding pin into eitherof these two additional holes, and hold the anteriolaterally facing flatsurface (the one associated with the hole into which the pin is fit) ofthe disc against the flat surface of the inserter/impactor opposite thepin. It should be understood that preferably, in order to facilitatethese two additional approaches, the angle separating the anteriorlyfacing flat surface of the disc and one of the anteriolaterally facingflat surfaces of the disc is equal to the angle separating theanteriorly facing flat surface and the other of the anteriolaterallyfacing flat surfaces.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1 a-h of the present application show front (FIG. 1 a), sidecutaway (FIG. 1 b), top (FIG. 1 c), perspective cutaway (FIG. 1 d),bottom cutaway (FIG. 1 e), top cutaway (FIG. 1 f), bottom perspective(FIG. 1 g), and top perspective (FIG. 1 h) views of an exemplaryartificial intervertebral disc for use with the present invention.

FIGS. 2 a-c show side (FIG. 2 a), perspective (FIG. 2 b), and close-upperspective (FIG. 2 c) views of a wedge plate inserter/impactor of thepresent invention.

FIGS. 3 a-d show bottom (FIG. 3 a), side (FIG. 3 b), top (FIG. 3 c), andside cutaway (FIG. 3 d) views of a distal end of a wedge plateinserter/impactor of the present invention.

FIGS. 4 a-b show top (FIG. 4 a) and side (FIG. 4 b) views of a wedgeplate inserter/impactor of the present invention holding an exemplaryartificial intervertebral disc.

FIGS. 4 c-e show top (FIG. 4 c), side (FIG. 4 d), and side cutaway (FIG.4 e) views of a distal end of a wedge plate inserter/impactor of thepresent invention holding an exemplary artificial intervertebral disc.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

While the invention will be described more fully hereinafter withreference to the accompanying drawings, it is to be understood at theoutset that persons skilled in the art may modify the invention hereindescribed while achieving the functions and results of the invention.Accordingly, the descriptions that follow are to be understood asillustrative and exemplary of specific structures, aspects and featureswithin the broad scope of the invention and not as limiting of suchbroad scope. Like numbers refer to similar features of like elementsthroughout.

A preferred embodiment of an artificial intervertebral disc (e.g.,artificial intervertebral disc 160) for use with the instrumentation ofthe present invention is referenced and described in the '356application, and the same description is hereby incorporated byreference herein. The artificial intervertebral disc illustrated inFIGS. 1 a-h of the present application is discussed herein withreference to such figures, as an example of an artificial intervertebraldisc suitable for use with the present invention.

Referring now to FIGS. 1 a-h, an artificial intervertebral disc of thepresent invention is shown in front (FIG. 1 a), side cutaway (FIG. 1 b),top (FIG. 1 c), side cutaway (FIG. 1 d), bottom cutaway (FIG. 1 e), topcutaway (FIG. 1 f), bottom perspective (FIG. 1 g), and top perspective(FIG. 1 h) views.

It should be understood that the illustration and reference herein tothe artificial intervertebral disc shown in FIGS. 1 a-1 h is merely toshow an example of one type of artificial intervertebral disc that iscontemplated by, encompassed by, and suitable for use with, the presentinvention, and that such illustration and reference herein is not meantto limit the scope of the present invention or limit the uses of thepresent invention. Rather, any other artificial intervertebral disc (orany other orthopedic device) having suitable features for beingmanipulated by the instrumentation and methods described herein arecontemplated by the present invention. Indeed, the features suitable formanipulation (e.g., angled flat surfaces with adjacent holes) areencompassed by the present invention, regardless of to what orthopedicdevice they may be applied. Other exemplary suitable artificialintervertebral discs include, but are not limited to, the artificialintervertebral discs described in the '160 application. The artificialintervertebral disc shown in FIGS. 1 a-1 h has features similar to thoseof these other suitable artificial intervertebral discs of the '160application, and it should be understood that such similar features arestructurally and functionally as described in the '160 application. Suchsimilar features include an inwardly facing surface of the upperbaseplate 164 a, and a convex structure 162 on the lower baseplate 168b, the convex structure 162 having an inwardly facing surface 164 b.

And, while the instrumentation described herein will be discussed foruse with the artificial intervertebral disc of FIGS. 1 a-1 h, suchdiscussions are merely by way of example and are not intended to belimiting of their uses. Thus, it should be understood that the tools canbe used with any of the artificial intervertebral discs disclosed in the'160 application, or any other artificial intervertebral disc having (orbeing modifiable or modified to have) suitable features therefor.Moreover, it is anticipated that the features of the artificialintervertebral disc (e.g., the flat surfaces and accompanying holes)and/or the static trials (e.g., the cylindrical trunks and flat surfacesand accompanying holes) that are used by the tools discussed herein tohold and/or manipulate these devices can be applied, individually orcollectively or in various combinations, to other trials, spacers,artificial intervertebral discs or other orthopedic devices asstand-alone innovative features for enabling such trials, spacers,artificial intervertebral discs, or other orthopedic devices to be moreefficiently and more effectively held and/or manipulated by the toolsdescribed herein or by other tools having similar features. In addition,it should be understood that the invention encompasses artificialintervertebral discs, spacers, trials (static or dynamic), and/or otherorthopedic devices, that have one or more of the features disclosedherein, in any combination, and that the invention is therefore notlimited to artificial intervertebral discs, spacers, trials, and/orother orthopedic devices having all of the features simultaneously.

A plurality of static trials are provided primarily for use indetermining the appropriate size of an artificial intervertebral disc tobe implanted (or whether a particular size of the artificialintervertebral disc can be implanted) into the distracted intervertebralspace (e.g., the artificial intervertebral disc 160 of FIGS. 1 a-1 h).Preferably, for each artificial intervertebral disc to be implanted, aplurality of sizes of the artificial intervertebral disc would beavailable. That is, preferably, a plurality of the same type ofartificial intervertebral disc would be available, each of the pluralityhaving a respective width and depth dimension combination that allows itto fit within a correspondingly dimensioned intervertebral space. Forexample, the plurality of artificial intervertebral discs could includeartificial intervertebral discs having widths being either 35 mm or 40mm, and depths ranging from 14 mm to 18 mm in 1 mm increments, for atotal of 10 discs. Accordingly, preferably, each of the plurality ofstatic trials for use with a particular plurality of differently sizedartificial intervertebral discs would have a respective width and depthdimension set corresponding to the width and depth of a respective oneof the plurality of differently sized artificial intervertebral discs.For example, the plurality of static trials for use with the set ofartificial intervertebral discs described for example could includestatic trials having widths being either 35 mm or 40 mm, and depthsranging from 14 mm to 18 mm in 1 mm increments, for a total of 10 statictrials. It should be understood that the artificial intervertebral discsand/or the static trials can be offered in a variety of dimensionswithout departing from the scope of the invention, and that thedimensions specifically identified and quantified herein are merelyexemplary. Moreover, it should be understood that the set of statictrials need not include the same number of trials for each artificialintervertebral disc in the set of artificial intervertebral discs, butrather, none, one, or more than one trial can be included in the trialset for any particular artificial intervertebral disc in the set.

A preferred embodiment of a wedge plate inserter/impactor of the presentinvention will now be described.

Referring now to FIGS. 2 a-4 e, FIGS. 2 a-c side (FIG. 2 a), perspective(FIG. 2 b), and close-up perspective (FIG. 2 c), and perspective (FIG. 4d) views of a wedge plate inserter/impactor of the present invention.FIGS. 3 a-d show bottom (FIG. 3 a), side (FIG. 3 b), top (FIG. 3 c), andside cutaway (FIG. 3 d) views of a distal end of a wedge plateinserter/impactor of the present invention. FIGS. 4 a-b show top (FIG. 4a) and side (FIG. 4 b) views of a wedge plate inserter/impactor of thepresent invention holding an exemplary artificial intervertebral disc.FIGS. 4 c-e show top (FIG. 4 c), side (FIG. 4 d), and side cutaway (FIG.4 e) views of a distal end of a wedge plate inserter/impactor of thepresent invention holding an exemplary artificial intervertebral disc.

It should be understood that the illustration and reference herein tothe artificial intervertebral disc shown in FIGS. 1 a-h of the presentapplication is merely to show an example of one type of artificialintervertebral disc that is contemplated by, encompassed by, andsuitable for use with, the present invention, and that such illustrationand reference herein is not meant to limit the scope of the presentinvention or limit the uses of the present invention. Rather, any otherartificial intervertebral disc (or any other orthopedic device) havingsuitable features for being used with the instrumentation and methodsdescribed herein are contemplated by the present invention. Indeed, thefeatures suitable for manipulation (e.g., angled flat surfaces withadjacent holes and/or opposing notches, and/or inwardly facing baseplatesurfaces) are encompassed by the present invention, regardless of towhat orthopedic device they may be applied. Other exemplary suitableartificial intervertebral discs include, but are not limited to, theartificial intervertebral discs described in the '160 application withregard to FIGS. 8 a-y, 9 a-t, 10 a-t, 11 a-j, and 12 a-o thereof and bythe accompanying descriptions therefor (e.g., embodiments identified asthe first, second, third, fourth, and fifth preferred embodiments of thefourth embodiment family, etc.). It should be noted that, as can be seenfrom FIGS. 1 a-h of the present application, that the artificialintervertebral disc shown in FIGS. 1 a-h of the present application hasfeatures similar to those of these other suitable artificialintervertebral discs of the '160 application, and it should beunderstood that such similar features are structurally and functionallyas described in the '160 application. Such similar features include aninwardly facing surface of the upper baseplate, and a convex structureon the lower baseplate, the convex structure having an inwardly facingsurface.

And, while the instrumentation described herein (e.g., theinserter/impactor) as well as the instrumentation described in the '356application (e.g., the inserter/impactor described therein) will bediscussed for use with the artificial intervertebral disc of FIGS. 1 a-hof the present application, such discussions are merely by way ofexample and not intended to be limiting of their uses. Thus, it shouldbe understood that the tools can be used with any of the artificialintervertebral discs disclosed in the '356 application or the '160application, or any other artificial intervertebral disc having (orbeing modifiable or modified to have) suitable features therefor.Moreover, it is anticipated that the features of the artificialintervertebral disc (e.g., the angled flat surfaces and the inwardlyfacing baseplate surfaces, and accompanying holes) that are used by thetool discussed herein (or in the '356 application) to hold and/ormanipulate these devices (certain features, it should be noted, werefirst shown and disclosed in the '160 application, the '127 application,and/or the '356 application) can be applied, individually orcollectively or in various combinations, to other trials, spacers,artificial intervertebral discs or other orthopedic devices asstand-alone innovative features for enabling such trials, spacers,artificial intervertebral discs, or other orthopedic devices to be moreefficiently and more effectively held and/or manipulated by the toolsdescribed herein (or in the '356 application) or by other tools havingsuitable features. In addition, it should be understood that theinvention encompasses artificial intervertebral discs, spacers, trials(static or dynamic), and/or other orthopedic devices, that have one ormore of the features disclosed herein (or in the '356 application), inany combination, and that the invention is therefore not limited toartificial intervertebral discs, spacers, trials, and/or otherorthopedic devices having all of the features simultaneously.

Preferably, for each artificial intervertebral disc to be implanted, aplurality of sizes of the artificial intervertebral disc would beavailable. That is, preferably, a plurality of the same type ofartificial intervertebral disc would be available, each of the pluralityhaving a respective width and depth dimension combination that allows itto fit within a correspondingly dimensioned intervertebral space. Forexample, the plurality of artificial intervertebral discs could includeartificial intervertebral discs having widths being either 35 mm or 40mm, and depths ranging from 14 mm to 18 mm in 1 mm increments, for atotal of 10 discs.

The inserter/impactor 4000 is provided primarily for holding, inserting,repositioning, removing, impacting, extracting, and otherwisemanipulating an artificial intervertebral disc having features suitablefor being manipulated by the inserter/impactor. (However, it can also beused to hold, insert, reposition, remove, impact, extract, and otherwisemanipulate any other orthopedic device having suitable featurestherefor. For example, it should be understood that distraction of anintervertebral space can be accomplished in conjunction with acooperating tool or spacer that can be gripped by theinserter/impactor.) Exemplary suitable artificial intervertebral discsinclude, but are not limited to, the artificial intervertebral disc 160described herein and the artificial intervertebral discs described inthe '160 application with regard to FIGS. 8 a-y, 9 a-t, 10 a-t, 11 a-j,and 12 a-o thereof and by the accompanying descriptions therefor (e.g.,embodiments identified as the first, second, third, fourth, and fifthpreferred embodiments of the fourth embodiment family, etc.). Regardingthe features suitable for being manipulated by the inserter/impactor4000, such features include those discussed above as being suitablefeatures on the disc 160, namely, an anteriorly facing flat surface onthe second (e.g., lower) baseplate of the trial or disc, flanked by twoanteriolaterally facing flat surfaces (one on each side of theanteriorly facing flat surface), and, to provide for holding of thetrial or disc for an anterior insertion approach, a hole spaced from theanteriorly facing flat surface, the hole having a longitudinal axisparallel to the anteriorly facing flat surface. Further regarding thefeatures suitable for being manipulated by the inserter/impactor, suchfeatures further include the inwardly facing surfaces of the baseplatesof the disc.

More particularly, the inserter/impactor 4000 includes a shaft 4020having a distal end 4040 that has angled flat surfaces 4200 a-ccorresponding to and fittable against angled flat surfaces of theartificial intervertebral disc (e.g., the surfaces 180 a-c of theartificial intervertebral disc 160) to be implanted. The distal end 4040has angled flat surfaces 4200 d-f corresponding to and fittable againstangled flat surfaces of the artificial intervertebral disc (e.g., thesurfaces 180 d-f of the artificial intervertebral disc 160) to beimplanted. The distal end 4040 has a wedge-shaped extension 4042including upper 4200 g and lower 4200 h wedge surfaces corresponding toand fittable against the inwardly facing surfaces of the artificialintervertebral disc (e.g., the lower surface 164 a of the upperbaseplate 168 a of the disc 160, and the upper surface 164 b of thelower baseplate 168 b of the disc 160, respectively) to be implanted.For example, in an anterior approach for the disc 160 (as shown in FIGS.4 a-e), 180 a and 180 d facing 4200 a and 4200 d, 180 b and 180 e facing4200 b and 4200 e, 180 c and 180 f facing 4200 c and 4200 f, and 164 afacing 4200 g and 164 b facing 4200 h.

The inserter/impactor 4000 holds the disc 160 in a preferred positionwith respect to the inserter/impactor 4000. (It should be understoodthat the surfaces of the wedge-shaped extension 4042 can be modifiedwithin the scope of the present invention to hold the disc 160 (oranother orthopedic device) at positions other than those illustratedherein.) In the illustrated embodiment of the inserter/impactor 4000 inuse with the disc 160, the preferred position is with the baseplates 168a,b of the disc 160 angle at 15 degrees of lordosis with respect to oneanother. More particularly, preferably, the upper and lower surfaces(e.g., 4200 g and 4200 h) of the wedge-shaped extension 4042 protrudefrom the distal end 4040 and are formed to hold the baseplates 168 a,bsuch that they are angled at 15 degrees of lordosis with respect to oneanother. A surface (e.g., lower surface 4200 h) of the wedge-shapeextension 4042 that mates with an inwardly facing surface of a baseplate(e.g., the lower baseplate 168 b) of a disc (e.g., 160) may becorrespondingly shaped (e.g., curved or flat) for interaction or matingwith the disc baseplate (e.g., the lower surface 4200 h of thewedge-shaped extension as illustrated is curved to accommodate thesurface of the shield of the disc). Preferably, the forward surface 4200i of the wedge-shaped extension 4042 has a concave curvature towards theshaft 4020 of the inserter/impactor 4000, also for accommodating thecurvature of the surface of the shield of the disc.

Also preferably with regard to the preferred positioning, the wedgesurfaces of the distal end 4040 protrude from a distance midway withrespect to the top and bottom of the distal end 4040 and span (e.g.,right to left or vice-versa) the entire distal face of the distal end4040, and the surfaces 4200 d-f above the wedge on the distal end 4040are respectively perpendicular to the wedge's upper surface 4200 g suchthat each is disposed in parallel with its respective correspondingsurface of the disc 160 when the disc 160 is held by theinserter/impactor 4000 at the appropriate lordosis angle. (And,accordingly, are angled approximately 15 degrees with respect to thesurfaces below the wedge 4200 a-c.) Preferably, for an anteriorapproach, the wedge-shaped extension 4042 is designed and shaped to fitwith its antero-lateral confronting surfaces (4200 d,f and 4200 a,c)tightly against the correspondingly antero-laterally facing surfaces(180 d,f and 180 a,c) of the disc 160, but such that its anteriorconfronting surfaces (4200 e and 4200 b) are slightly spaced from theanteriorly facing surfaces (180 d and 180 b) of the disc 160, when thedisc is held by the inserter/impactor 4000. This is primarily to addressmanufacturing issues (in some cases, tolerances may not be adequatelydefined to ensure that all of those surfaces fit tightly against theircorresponding surfaces), so that if there are manufacturing anomalies,any slight tolerance differences that may exist are nevertheless stilladequate to ensure at least the tight fitting of the antero-lateralconfronting surfaces, so that manipulation of the disc 160 is possible(e.g., in the manner of a wrench against an angled nut). This can beachieved, e.g., by designing the anterior confronting surfaces (4200 eand 4200 b) to each be slightly greater in length than the correspondinganteriorly facing surfaces (180 e and 180 b) of the disc baseplates,while still being angled with respect to the antero-lateral confrontingsurfaces (4200 d,f and 4200 a,c) at the same angle the antero-laterallyfacing surfaces (180 d,f and 180 a,c) of the disc baseplates are angledwith respect to the anteriorly facing surfaces (180 e and 180 b) of thedisc. The increased length of the anterior confronting surfaces on thewedge extension results in the slight clearance between the anteriorlyfacing surfaces (180 e and 180 b) of the disc and the correspondinganterior confronting surface (4200 e and 4200 b) of the wedged distalend, thereby ensuring that the disc will be fully seated against theantero-lateral confronting surfaces of the distal end despite possiblemanufacturing, material or other inevitable variations in tolerances ofthe artificial intervertebral disc or the inserter/impactor. As notedabove, similar in this regard to the manner in which a wrench engages anut, this fitting increases the mechanical advantage towardrepositioning the disc in the intervertebral space. It should be noted,inasmuch as the inserter/impactor 4000 described herein can engage thedisc from the antero-lateral angles as well, the anterior confrontingsurfaces (4200 e and 4200 b) should also be longer than theantero-laterally facing surfaces (180 d,f and 180 a,c) of the disc, sothat a similar fitting occurs when the disc is held from theantero-lateral angles. Stated broadly, the primary confronting surfaces(e.g., the anterior confronting surfaces) of the inserter/impactor arepreferably slightly longer than the primary confronted surfaces (e.g.,anteriorly facing surfaces) of the disc for any given holdingorientation.

Further, the inserter/impactor 4000 includes a holding pin 4080 thatextends from the wedge 4042 along a longitudinal axis of the shaft 4020,the pin 4080 having a distal end 4100 that is bent downwardly. Theholding pin 4080 is spring loaded (e.g., by a spring 4090) in a centralchannel of the shaft 4020, so that it is biased toward the shaft 4020(preferably, the bent end 4100 of the pin 4080 prevents it from enteringthe central channel). The holding pin 4080 is restricted from upwardlylateral movement with respect to the distal end of the inserter/impactorby the presence of the wedge-shaped extension 4042 of the distal end4040 of the inserter/impactor 4000. More particularly, with anyattempted upward movement of the holding pin 4080, the pin encountersthe upper surface of the channel in which the pin 4080 travels,preventing any such upward movement. The holding pin 4080 is preferablyheat treated (e.g., cold formed) to increase material quality (e.g.,strength).

A flange 4110, mechanically connected to the pin 4080 and translatingadjacent the shaft 4020, can be pushed distally to overcome the bias ofthe spring 4090 to space the pin 4080 away from the wedge 4042. (Analternative configuration is one in which the flange 4110 and the pin4080 are formed from a single piece, rather than being mechanicallyconnected.) In this extended position, the pin 4080 can be inserted in ahole (e.g., 182 b) in the baseplate (e.g., 168 b) of the artificialintervertebral disc (e.g., 160). Releasing the flange 4110 allows thespring 4090 to pull the pin 4080 back, causing the anteriorly facingsurface 180 b of the baseplate 168 b to be held against the lowercentral flat surface 4200 b of the inserter/impactor 4000 and theanterioloaterally facing flat surfaces 180 a,c of the artificialintervertebral disc 160 to be held against the other corresponding flatsurfaces 4200 a,c of the inserter/impactor 4000. This can be furtherunderstood in light of the description of the manner in which theinserter/impactor of the '160 application functions to grip anorthopedic device, which is included in the '160 application andincorporated by reference herein. Simultaneously, the anteriorly facingsurface 180 e of the baseplate 168 a is pulled against the upper centralflat surface 4200 e of the inserter/impactor 4000 and theanterioloaterally facing flat surfaces 180 d,f of the artificialintervertebral disc 160 is pulled against the other corresponding flatsurfaces 4200 d,f of the inserter/impactor 4000. Additionally, the upperand lower wedge surfaces (4200 g,h) interfere between the inwardlyfacing surfaces 164 a,b of the disc baseplates, causing the baseplate tobe angled at a 15 degree lordosis angle, with the lower surface 164 a ofthe upper baseplate 168 a held against the upper surface 4200 g, and theupper surface of the shield being held against the lower surface 4200 h,as best shown in FIGS. 4 a-e.

A knob 4120, threaded on the shaft 4020, can be rotated about thelongitudinal axis of the shaft 4020 to push the flange 4110 fartherproximally, to pull the pin 4080 tighter and therefore lock its position(the interference of the threads of the knob-shaft interface preventsthe knob 4120 from moving distally unless the knob 4120 is reverserotated to effect that result) to more securely hold the baseplate 168b, and reverse rotated to unlock and loosen the pin 4080.

When the disc 160 is held in this manner, rotation of the disc 160 abouta longitudinal axis (of the disc 160) relative to the inserter/impactor4000 is prevented by interference of the corners of the disc's 160 flatsurfaces (180 a-c and 180 d-f) and the corners of theinserter/impactor's 4000 flat surfaces (4200 a-c and 4200 d-f), similarto the manner in which a wrench holding a nut prevents rotation of thenut relative to the wrench. Further, the holding of the disc 160 in thismanner allows for some repositioning of the disc 160 in theintervertebral space via rotation of the disc 160 in either directionabout the longitudinal axis of the intervertebral space. Further whenthe disc is held in this manner, rotation of the disc about a lateralaxis (of the disc 160) relative to the inserter/impactor 4000 isprevented by interference of the inwardly facing surface 164 a of thefirst baseplate (e.g., upper baseplate) of the disc and the uppersurface 4200 g of the wedge on the distal end 4040, and by interferenceof the inwardly facing surface 164 b of the second baseplate (e.g.,lower baseplate) of the disc and the lower surface 4200 h of the wedgeon the distal end 4040. Accordingly, the holding of the disc in thismanner allows for some repositioning of the disc in the intervertebralspace via rotation of the disc in either direction about thelongitudinal or latitudinal axis of the intervertebral space

In some embodiments, when the artificial intervertebral disc 160 is heldby the inserter/impactor 4000, the flat surfaces 180 a-c are moreclosely confronted by the angled flat surfaces 4200 a-c of theinserter/impactor 4000, compared with the flat surfaces 180 d-f beingless closely confronted by the angled flat surfaces 4200 d-f of theinserter/impactor 4000. As such, the structure of the artificialintervertebral disc 160 having the flat surfaces 180 d-f (e.g., theupper baseplate 168 a) has slightly more rotation and angulation freedomrelative to the inserter/impactor 4000 when being held, compared to thestructure of the artificial intervertebral disc 160 having the flatsurfaces 180 a-c (e.g., the lower baseplate 168 b). This permits theartificial intervertebral disc 160 to adjust to the intervertebral space(e.g., to the angulation of the adjacent vertebral endplates, definingthe intervertebral space, relative to one another) as it is beinginserted thereinto. That is, typically, the adjacent vertebral endplateswill be lordotically angled with respect to one another as a result ofthe intervertebral space being prepared and distracted.

Preferably, in order to provide for a holding of the disc 160 for twoadditional (here, anteriolateral) insertion approaches, each disc 160also includes two additional holes 182 a and 182 c, one (e.g., 182 a)spaced apart from one of the anteriolaterally facing flat surfaces (e.g.180 a), and the other (e.g. 182 c) spaced apart from the other of theanteriolaterally facing flat surfaces (e.g. 180 c). Accordingly,operation of the inserter/impactor 4000 can fit the holding pin 4080into either of these two additional holes 182 a or 182 c, and hold theassociated anteriolaterally facing flat surface (the one associated withthe hole into which the pin 4080 is fit) of the disc 160 against theflat surface of the inserter/impactor 4000 opposite the pin 4080. Forexample, in a first anteriolateral approach for the disc 160, 180 a and180 d facing 4200 b and 4200 e, 180 c and 180 f not confronted, and 180b and 180 e facing 4200 c and 4200 f, and in a second anteriolateralapproach for the disc 160, 180 b and 180 e facing 4200 a and 4200 d, 180a and 180 d not confronted, and 180 c and 180 f facing 4200 b and 4200e. It should be understood that preferably, in order to facilitate theseadditional approaches, the angle separating the anteriorly facing flatsurface of the disc 160 and one of the anteriolaterally facing flatsurfaces of the disc 160 is equal to the angle separating the anteriorlyfacing flat surface and the other of the anteriolaterally facing flatsurfaces. Preferably, the surfaces are angled with respect to oneanother at an angle of 33.4 degrees.

It should also be understood that the inclusion of additional adjacentangulated surfaces (or placing the angulated surfaces in other locationson the disc or other orthopedic device), and/or including correspondingholes adjacent to such surfaces, can provide the surgeon with additionalapproaches, e.g., other anteriolateral approaches, directly lateralapproaches, posteriolateral approaches, and/or directly posteriorapproaches. For example, a trial or disc can have angled surfaces (andcorresponding holes) along the entire perimeter of one or both of thebaseplates, and thus enable the surgeon to engage the trial or disc froma number of angles, including anterior, posterior, lateral,anteriolateral, and posteriolateral angles.

The inserter/impactor 4000 further includes at a proximal end a cap 4140for use as an impact surface if the disc 160 must be impacted furtherinto the intervertebral space after insertion, or forcibly extractedfrom the intervertebral space. A mallet can be used to strike the cap4140 (in a distal direction for impaction, or in a proximal direction(using the flange of the cap 4140) for extraction). It should be noted astriking of the cap 4140 will translate the striking force to thebaseplates through the shaft 4020 and the flat surfaces, but will notdamage the holding pin 4080 because the holding pin 4080 is springloaded in the central channel and thus buffered from the striking forcethereby. The distal end 4040 of the inserter/impactor 4000 furtherpreferably includes at least one vertebral body stop 4202 that protrudeslongitudinally with respect to the shaft 4020, from the surfaces of thedistal end. The stops help prevent the inserter/impactor from being usedto insert the disc (or other orthopedic device) too far into theintervertebral space.

Accordingly, the inserter/impactor 4000 can be used to grip theartificial intervertebral disc to be implanted, and hold the same duringinsertion and/or removal of the same, and is useful for a variety ofsurgical approach angles.

While there has been described and illustrated specific embodiments ofinstrumentation, it will be apparent to those skilled in the art thatvariations and modifications are possible without deviating from thebroad spirit and principle of the invention. The invention, therefore,shall not be limited to the specific embodiments discussed herein.

1. An instrument for holding an intervertebral implant comprising: ashaft having a proximal end, a distal end and a longitudinal axis thatextends between the proximal and distal ends; a body attached to thedistal end of said shaft, said body having a first set of substantiallyflat surfaces that are angled relative to one another and a wedge-shapedprojection extending distally beyond said first set of substantiallyflat surfaces; a pin having a hooked end being extendable from anopening in said wedge-shaped projection, said pin being movable betweena retracted position and an extended position.
 2. The instrument asclaimed in claim 1, further comprising a spring coupled with said pinfor normally urging said pin into the retracted position.
 3. Theinstrument as claimed in claim 1, further comprising a flange coupledwith said pin, said flange being movable relative to said shaft andtoward the distal end of said shaft for extending said pin from theopening in said wedge-shaped projection.
 4. The instrument as claimed inclaim 1, wherein said pin has a first section that extends along thelongitudinal axis of said shaft and said hooked end that extends along asecond axis that is substantially perpendicular to the longitudinalaxis.
 5. The instrument as claimed in claim 1, wherein said hooked endcomprises a single hook.
 6. The instrument as claimed in claim 1,wherein said body further comprises a second set of substantially flatsurfaces that are angled relative to one another, said second set ofsubstantially flat surfaces being spaced from said first set ofsubstantially flat surfaces.
 7. The instrument as claimed in claim 6,wherein said wedge-shaped projection is located between said first setof substantially flat surfaces and said second set of substantially flatsurfaces.
 8. The instrument as claimed in claim 1, wherein saidwedge-shaped projection has a concave surface.
 9. The instrument asclaimed in claim 8, wherein said wedge-shaped projection furthercomprises an upper surface extending from said concave surface of saidwedge-shaped projection toward the proximal end of said shaft and alower surface extending from said concave surface of said wedge-shapedprojection toward the proximal end of said shaft.
 10. The instrument asclaimed in claim 9, wherein said upper surface of said wedge-shapedprojection and said lower surface of said wedge-shaped projection areangled relative to one another.
 11. The instrument as claimed in claim3, further comprising a knob coupled to said shaft, wherein said knob isrotatable in a first direction for locking said flange from movementrelative to said shaft and is rotatable in a second direction forunlocking said flange to allow for movement of said flange relative tosaid shaft.
 12. The instrument as claimed in claim 1, further comprisinga vertebral body stop extending upwardly from said body.
 13. Aninstrument for holding an intervertebral implant comprising: a shafthaving a proximal end, a distal end and a longitudinal axis extendingbetween the proximal and distal ends; a wedge-shaped projectionextending from the distal end of said shaft, said wedge-shapedprojection having upper and lower surfaces that are angled relative toone another; a pin provided at the distal end of said shaft and beingextendable through an opening in said wedge-shaped projection, said pinhaving a first section that extends along the longitudinal axis of saidshaft and a second section having a hooked end that extends along anaxis that is substantially perpendicular to the longitudinal axis, saidpin being movable relative to said wedge-shaped projection between aretracted position and an extended position; and a spring coupled withsaid pin for normally urging said pin into the retracted position. 14.The instrument as claimed in claim 13, further comprising a flangecoupled with said pin for selectively extending said hooked end of saidpin from said wedge-shaped projection.
 15. The instrument as claimed inclaim 13, wherein said wedge-shaped projection further comprises aconcave surface located between said upper and lower surfaces that areangled relative to one another.
 16. The instrument as claimed in claim13, wherein the distal end of said shaft further comprises a first setof substantially flat surfaces that are angled relative to one another,said first set of substantially flat surfaces being located adjacentsaid wedge-shaped projection.
 17. An instrument for holding a spinalimplant comprising: a shaft having a proximal end, a distal end and alongitudinal axis extending between said proximal and distal ends; abody attached to said distal end of said shaft, said body having a firstset of substantially flat surfaces that are angled relative to oneanother, a second set of substantially flat surfaces that are angledrelative to one another, said first and second sets being spaced fromone another, and a wedge-shaped projection located between the first andsecond sets and extending distally beyond said first and second sets; apin provided at the distal end of said shaft, said pin having a hookedend, said pin being movable relative to said shaft between a retractedposition and an extended position, wherein said hooked end of said pinis extendible from an opening in said wedge-shaped projection; and aspring coupled with said pin for normally urging said pin into theretracted position.
 18. The instrument as claimed in claim 17, furthercomprising a flange coupled with said pin for selectively extending saidhooked end of said pin from said body.
 19. The instrument as claimed inclaim 17, wherein said wedge-shaped projection has upper and lowersurfaces that are angled relative to one another.
 20. The instrument asclaimed in claim 17, wherein said wedge-shaped projection has a concavesurface extending between said upper and lower surfaces of saidwedge-shaped projection.